Comparison of Two IUDs Among Cape Town HIV-positive Women

This study is ongoing, but not recruiting participants.

Sponsor:

FHI 360

ClinicalTrials.gov Identifier:

NCT01721798

First Posted: November 6, 2012

Last Update Posted: August 2, 2017

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
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This study will inform international medical guidelines as to whether the Levonorgestrel intrauterine device (LNG IUD), a highly effective long-acting reversible contraceptive method, is safe and acceptable as compared to the copper intrauterine device (C-IUD) for HIV-positive women in Cape Town, South Africa. If the LNG IUD is found to be safe and acceptable, the introduction of this method to HIV positive women in developing countries could significantly reduce unplanned pregnancy and mother-to-child transmission of HIV, and confer non-contraceptive benefits to HIV-positive women in Sub-Saharan Africa.

Compare LNG IUD safety to the safety of the C-IUD with respect to genital HIV shedding, a surrogate for potential for HIV transmission, overall and in the presence and absence of ART. [ Time Frame: 24 months ]

Secondary Outcome Measures:

Compare LNG IUD safety to the safety of the C-IUD with respect to HIV progression as measured by changes in plasma viral load (VL) at 6 months between the two pre-ART study arms. [ Time Frame: 24 months ]

Duration & Follow-up: Approximately 48 months in total. Recruitment will take approximately 24 months. After enrollment, each participant will be followed for 24 months.

Primary Objectives: To compare LNG IUD safety to the safety of the C-IUD with respect to genital HIV shedding, a surrogate for potential for HIV transmission, overall and in the presence and absence of ART.

Secondary Objectives: 1) To compare LNG IUD safety to the safety of the C-IUD with respect to HIV progression as measured by changes in plasma viral load (VL) at 6 months between the two pre-ART study arms. 2) To explore LNG IUD safety with respect to non-HIV related outcomes, including hemoglobin change, incidence of sexually-transmitted infections (STIs) and pelvic inflammatory disease (PID). 3) To measure LNG IUD acceptability through device continuation and other measures for the LNG IUD as compared to the C-IUD. 4) To compare three genital tract sampling methods to determine which provides optimal recovery of HIV RNA and immune mediators over a series of three visits.

Primary Endpoints: Change in detection and quantity of HIV RNA genital VL measures between study arms at baseline and 6 months, and over 24 months following IUD insertion.

Secondary Endpoints: 1) Measures of HIV disease progression, including CD4 change, time to ART initiation, and mean plasma VL change from baseline to 6 and through 24 months among pre-ART women. 2) Hemoglobin change and incidence of STIs and PID for all participants through 24 months. 3) IUD continuation and expulsion rates between study arms comparing different IUDs over a 24-month period and acceptability measures through quantitative and qualitative methods. 4) Comparison of female genital tract sampling methods for recovery of HIV RNA as measured by VL and immune mediators (e.g. cytokines).

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Ages Eligible for Study:

18 Years to 40 Years (Adult)

Sexes Eligible for Study:

Female

Gender Based Eligibility:

Yes

Accepts Healthy Volunteers:

Yes

Criteria

Inclusion Criteria

Willing and able to provide written informed consent (IC) to be screened for and to participate in the trial

Interested and willing to use the IUD as a family planning method.

Between 18 to 40 years of age (inclusive): This age range includes women during their years of greatest fertility and 18 is the age of majority for research consent in South Africa.

Willing to participate in all aspects of the study and to comply with study procedures and visits, for 24 months, including:

Be randomized

Adhere to follow-up schedule and willing to be contacted by site staff between study visits (by phone and/or in person)

Provide contact/locator information

Agree for site staff to review clinic chart to confirm HIV status

Has documented HIV infection

For pre-ART entrants:

ART-ineligible at screening, based on current South African ART guidelines

Be at least 6 months post-delivery and not pregnant or desiring pregnancy for the next 30 months.

For ART-using entrants:

ART-use demonstrated by clinical records reflecting laboratory measures consistent with ART use and evidence of viral suppression (plasma VL<1000 copies/mL) at the most recent VL measure.

Be at least 6 weeks post-delivery and not pregnant or desiring pregnancy for the next 30 months.

Intending residence in Cape Town area for next 30 months

No documented or known history of infertility or sterilization

No gross evidence of cervical neoplasia on examination

No prior history of ectopic pregnancy

No history of or suspected hormonally-dependent neoplasm or undiagnosed abnormal vaginal bleeding

Local language fluency and comprehension

Not participating in any other clinical trial with a biomedical intervention

Have no condition that, based on the opinion of the Site PI, would preclude provision of informed consent, make participation in the study unsafe, or complicate interpretation of data.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01721798